Surgical package



Dec. 22, 1964 P. E. REGAN, JR 3,162,307

SURGICAL PACKAGE 1 3 Sheets-Sheet l T112.

Filed July 10, 1963 IN VEN TOR.

ATTORNEY 1964 P. E. REGAN, JR 3,162,307

SURGICAL PACKAGE Filed July 10, 1965 3 Sheets-Sheet 2 INVENTOR. 41/4 5 fifaw/w/k.

ATTORNEY 2 1964 P. E. REGAN, JR 3,162,307

SURGICAL PACKAGE Filed July 10, 1965 5 Sheets-Sheet 3 INVENTOR. 1941/4 A? xPevA/v J?! ATTOR NE Y product to sandwich the United States Patent Oflice Patented Dec. 22, 1964 3,162,307 SURGICAL PACKAGE Paul E. Regan, In, Somerville, NJ, assignor to Ethicon, Inc., a corporation of New Jersey Filed July 10, 1963, Ser. No. 293,969 13 (Ilaims. (til. 2tl663.3)

The present invention relates to sterile surgical packages, more particularly to sterilized and sterilizable packages for surgical products such as sutures, needles, and the like.

Surgical products of this type commonly have been packaged in double enclosures both of which are hermetically sealed. At one time it was most common to package products, such as sutures, inside sealed glass tubes which, in turn, were enclosed within a sealed can or jar. This type of package has been virtually replaced wtih sealed double envelopes, i.e., the sterile product is sealed inside an inner envelope and the inner envelope containing the product is sealed inside a second or outer envelope.

Normally, double envelope packages of the type re ferred to above have employed thermoplastic materials and have been sealed by heat or by a thermoplastic adhesive. In most cases this means that the packages can be sterilized only by irradiation or by sterilizing gases. After sterilization by the manufacturer, all parts of the package are sterile with the exception of the exposed surfaces of the outer envelope. Just prior to use, the outer envelope is opened to enable the sterile inner envelope to be placed in a sterile zone in a surgical area. If the inner envelope is not opened at all, it remains as a sterile enclosure for the product. However, its outer surface must be resterilized before it can again be placed in a sterile zone. Since most hospitals have only heat sterilizing equipment such as a steam autoclave, the inner envelope must be returned to the manufacturer for resterilization.

It may be desirable to enclose a quantity of sterile products such as several suture lengths, needles, surgical sponges, or the like, in one inner envelope. However, if this is done the inner envelope must be capable of being reclosed prior to resterilization in order to protect the product. This is not possible with the conventional sealed inner envelope.

According to the present invention, a double envelope package for sterile surgical products is provided which has an inner envelope which is resterilizable whether or not it is opened; and which is re-useable because it can be reclosed and resterilized after it is opened. The package of this invention comprises a conventional outer envelope and a stiff fiber-board inner envelope. The outer envelope preferably include one transparent panel for viewing the inner envelope .and reading printing presented on one side of the inner envelope. The outer envelope is hermetically sealed by the manufacturer to provide a sterile package, and the inner envelope is detachably closed by mechanical means.

The inner envelope comprises a panel on which the product is adapted to be positioned and which cover one side of the product, a flap foldably connected to one edge of the panel and adapted to be folded over the product between the panel and the flap, and detachable mechanical means for holding the flap and the panel in their folded over positions with respect to one another. Means also are provided for holding the product on the panel and preventing movement of the product beyond the panel in a direction parallel to the above referred-to folding edge. Preferably, these holding means are in the form of holding flaps at opposite ends of the panel which fold inwardly over the panel at right angles to the first-mentioned flap.

In one embodiment, the detachable mechanical means may be in the form of a slot and a detent presented by corresponding flap and panel portions. The detent or the slot may extend from an additional latching flap foldably connected to the panel or one of the other flaps.

In a preferred embodiment of this invention for suture packages, the first-mentioned flap is foldably connected to the bottom edge of the panel and is adapted to cooperate With a top flap foldab ly connected to the top edge of the panel for holding the product. In this embodiment, the panel has a dispensing section at one end and the top and bottom flaps terminate short of the dispensing section. Opposite side flaps also are provided and the side flap attached to the dispensing section, hereinafter sometimes called the opening flap, preferably terminates short of the top and bottom flaps. All of the flaps are adapted to be held in their folded down position by a fiber-board sleeve which slides over the panel and the flaps. When the sleeve is moved with respect to the panel to uncover the opening flap only, this flap may be folded upwardly to expose one end of the sterile product positioned on the dispensing section of the panel for ready access thereto. One of the advantages of this embodiment is that a sterile product such as a coil of sutures may be placed on the panel and fixed in position very easily merely by folding down the flaps, and then the flaps may be held in position merely by inserting the panel into the sleeve.

In still another embodiment of this invention, the package just described is-modified by the addition of means for securing the panel in the sleeve to provide a tamper-proof feature. The opening flap on the panel may be modified to present a detent adapted to cooperate with a slot defined in one side of the sleeve to form the latch. The detent is designed so that it is easily inserted in the slot but is difficult to remove. Thus, the inner envelope normally is opened by breaking off the end of the detent, thereby giving a clear indication that the envelope has been used or tampered with.

Other and further advantages of this invention will be apparent from the following description and claims taken together with the drawings wherein:

FIG. 1 is a view in perspective of a sterile package according to a preferred embodiment of this invent-ion for packaging sutures;

FIG. 2 is a somewhat enlarged view, partly in section and partly in elevation, taken along the line 22 of FIG. 1;

FIG. 3 is a view in perspective of the back of the inner envelope of the package of FIG. 1;

FIG. 4 is a view in perspective of the front of the envelope of the package of FIG. 1 showing the positioning panel partially removed therefrom with its opening flap folded upwardly to expose the end of a coil of sutures;

FIG. 5 is a view in perspective of the positioning panel and flaps of the envelope of the preceding figures showing all of the flaps folded open;

FIG. 6 is a view in perspective of the back of one end of the envelope of the preceding figures showing the removal of the first resterilization tab;

FIG. 7 is a view in perspective of the tied end of the suture loop after the sutures have been straightened out;

FIG. 8 is a view in perspective of the back of an inner envelope according to a somewhat different embodiment of the invention and showing a latch for securing the positioning panel to the sleeve;

FIG. 9 is a view in perspective of the embodiment of FIG. 8 and showing the detent presented by the opening flap before it is inserted through the slot in the sleeve;

FIG. 10 is a view in perspective showing the front of the envelope of FIG. 8;

' by any other suitable means.

FIG. 11 is a plan view of the positioning panel and open;

FIG. 12 is 'a view in perspective of a ing to a still different embodiment of this invention;

FIG. 13 is 'a view'in perspective of the inner envelope.

of'the package of FIG. 12;

FIG. "l4.is1an enlarged sectional view taken'along the line.14.14,of FIG. 13 and showing the latch for holding the flaps down over the positioning panel of the envelope; 7

FIG. 15 is a partially cut-away view in perspective'of package. accord;

' section38 independently of the top and bottom flaps.

the envelope .of the preceding figures" showing the top and'bottorn flaps partially open.

the

Referring to FIGS. l-7 of drawings, there is shown a package'according toa preferred embodiment of this.

invention for packaging sutures, which comprises aher- -metically sealed outer envelope 21, "a stiff fiber-board inner envelope 22.and a. sterile surgical product, i.e., a coil of sutures 23, inside the inner envelope. The outer envelope'21 comprises a transparent top panel 24 and a bottom panel 25 sealed together dong their edges to when folded down on the panel 32, the opening flap 36 terminates short ofthe top and bottom flaps 34 and 33 so that the opening flap 36'does not tuck under the top and bottom flaps 34 and 33, and therefore is capable of being folded in and out of posit-ion over the dispensing However, when the positioning panel 32 is fully inserted in the sleeve 37, the sleeve covers the leading end 39 of the opening flap. The leading end 39 of the flap 36 is tapered so thatit' fits easily into the sleeve 37 and the outermost portion 4-1 'of"the1clispens'ing section 38' and a corresponding portion of the opening flaps 36 are widened to prevent the sleeve 37 from passing completely over the dispensing section 38. Thus, top and bottom portions 42 and 43 of the opening flap immediately adjacent the "inclined leading end 39 thereof are adapted to ,engage the top and bottom edges of the sleeve 37 when the sleeve is pressed over the panel 32 to hold-the sleeve in position with respect thereto.

The sleeve 37, itself, is formed from a single sheet of paperboardwhich is folded and secured togetherby an provide a hermeticallysealed strippable sterilizable e'nclosure for the sleeve 22 and its contents; 7 7 bottom panels 24 and 25 may be formed of any sheet materials which will actas the Thetopand 25. desired barriers for a stenili'zable package of this type and which may be sealed a together a'sishown and'stripped apartaszwill. be described hereinafter. Typically, the transparent'top panel 24 is a laminate of Mylar and polyethylene and' the bottom panel 25 is a laminate of foil and paper held together by a polyethylene adhesive. The top and bottom panelsa24 and 25 are superimposed with the polyethylene .side of ;the top panel 24 in contact with the paperside of. the bottom panel 25 and thepanels are heat, sealed to one anotheralong a strip 26' whichforms a shallow; peak 27 at one end of the package. The peak'27 is spaced some- -what;fro 1n the adjacent endsjof stripping flaps 28 and 2' for opening-the package. The 'fiaps 28 and 29 are pulled apart to separate the panels andbreak the sealwhen it is desired to remove the inner envelope 22"fro-rnthe outer envelope1 21= Printing 31 is applied to one side of the inner envelope 22 to identify its contents and the inner envelope is inserted so that it may read through the transparent side 24 of the outer .the panels to provide ofthesleeve'37, the designation firstautoclave,"second adhesive along a folded strip 44 facing theback "of the sleeve. Also attached to the folded, strip'44 is a set of three sterilizing tabsfqiS. The tabs 45 are part of a flap fwhichextends over one end of the sleeve and are formed by three spaced perforated tear lines 46 which are adapted tobepsed for detaching the tabs 45 successively from thesleeve. The top tab is printed with the word sterile, meaning that the sleeve and contents issterile and in the condition in which it is received from the. manufacturer. Underneath'the first, second and third tabs'on the face autoclave, and third autoclave, are printed. Each time the'inner envelope 22issterilized one of the tabs 45 is removed to expo'se theapprcpriate designation and thereby-indicatehow manytimes the envelopehas been resterilized r f In use, the outer envelope -21 isstripped-- open-and the inner envelope 22 is deposited in a sterile zone in an op- "erating area. 'Atthis point the inner envelope22is sterile envelope 21. The resulting -package may be sterilized I by irradiation after the outer envelope is sealed, or by-the use of a sterilizing gas such as'ethylene-oxide which enters the mouth of the outer envelope before it is sealed, or

to be positioned and which covers one side of the sutures, a bottom flap 33 foldably connected to the bottom edge ofthe panel 32 23 to sandwich the sutures between the 'flap 3 3, and a top flap '34 foldably connected to edgeof the panel forcooperating with theibottorn flap 33 in holding the sutures in position on the panel. A first and adapted to be folded over the sutures panel 32 and the formed from relatively stiff 'sterilizable sheet material such as virgin paperboard ap- V the top inside and out. If thesutures 23 inside the inner envelope I are needed,-the "sleeve 37, may be drawn partially off the panel, as shown in 1 16.. 4, to uncover the end of the opening flap 36. Themthe opening flap 36'is folded back to expos'e the end of the-suture loop 23 or a holding tab 47 attached thereto. For convenience atthis point, a

. 'perforated fold-line48 is' providedin thepanel itself at the inner'end. of the dispensing section 38 so that the v dispensing section and the opening flap 36' may befolded under theremainder of thep'ositioning'panel32 in a reverse bend to present theholding tab 47 at the end of the suture loo'p'free of any' package structure. The loop of sutures 23 .then maybe removed easily from the package by drawing it outwardly by the tab 47 In the package shown in FIGS. 1-7, several sutures 23 .are included in theJloop. In 'use the suture loop may be held by the tab 47 and th'enfstretched or fshaken so .that one or more of the sutures may b'e'removedeasily therefrom. If all of thesutures 23 .are not used, those remainingrnay be Tl'oo'ped andplaced on'top of the positioning'panel .32, as shown in FIG. 5, and positioned on the panel'by folding the first side flap 35 and the bottomand topflaps 33 and side flap 35 and an opening flap 36 alsoare-foldably. connected to the'opposite side edges of theflpositioni'ng panel 32. All of the flaps are adapted to be folded down over the panel'32, and a fiber-board sleeve 37 is provided for fitting over the panel 32 .and holding the flaps in their folded down positions thereon, as shown in FIGS. 1 and 3.

The positioning'panel 32 has a dispensing section 38 at one end thereof, and the top and bottom flaps 34 and 33 terminate short of the dispensing section. The opening flap 36 is attached to the panel at the end of the dispens- -ing section 38 so that the opening flap 36'is adapted to fold down over the dispensing section '38. However,

' 34 successively down over the loop. Th'en'the opening flap 36is. folded down over the panel 32 and the panel is inserted in the; sleeve 37. At this point, the sutures 23 are completely enclosed inside the inner envelope 22 and the inner envelope 22 isready for resterilization. After resteriliz ation as described above, the fsutures 23. are protected againstcontamination by the inner envelope.

Referring to FIGS. 8-1l, there isTshown a somewhat different embodiment of an inner envelope according to this invention. The positioning panel 32, jthe top flap 34, the bottom flap .33, and. the first side fiap35 are substantially identical with the'same parts of the envelope 22 of the embodiment 10f FIGS. 1-7. However, a "modified opening flap 51 and sleeve 52 have been incorporated. The purpose of this modification is to provide means for latching the positioning panel 32 in position in the sleeve 52 and provide a tamper-proof feature. Since in this embodiment it may not be desirable to resterilize the inner envelope, the sterilization tabs of the sleeve of FIGS. 1-7 and corresponding indicia also have been removed from the sleeve 52.

The latching means comprises two parts, i.e., a detent 53 presented by the opening flap 51, and a cooperating slot 54 in' one side of the sleeve. In the embodiment of FIGS. 8-11, the slot 54 is cut in the back side of the sleeve 52 adjacent one end thereof. The slot 54 is curved in the shape of a C with its convex side adjacent the end of the sleeve. Thus, the slot 54 is inclined away from its ends 55 toward the end of the sleeve. The detent 53 is positioned on the opening flap 51 so that it will be aligned with the slot 54 when the flap 51 and the sleeve 52 are brought together. The detent has a convexly curved leadingedge 56 which is inclined from its center toward each of its ends 57, and presents trailing latching portions 58 behind the ends 57 of its leading edge 56. The slot 54 in the sleeve is wider across its ends 55 than the detent 53 is across its ends 57, so that the detent may be inserted easily into and through the slot when the panel 32 is inserted in the sleeve 52 with its flaps folded down. Preferably, the detent 53 is inserted through the slot 54 from the underside of the slot so that the detent appears outside the sleeve 52 when the panel is latched to the sleeve, as shown in FIG. 8.

After the detent 53 passes through the slot 54, the

tongue-like portion 59 of the sleeve defined by the slot tends to press the detent 53 outwardly above the level of the sheet making up that side of the sleeve, as shown in FIG. 8. When it is attempted to remove the panel from the sleeve, the latching portions 53 of the detent 53 catch on the inclined curved edge of the slot 54 and prevent further outward movement of the panel. Because of the upward pressure of the tongue-like portion 59 on the detent 53, it is very difficult to remove the dentent 53 from the slot 54 without tearing the detent. To provide a tamper-proof feature, instructions may be printed on the sleeve 52 indicating that the detent 53 should be torn to allow removal of the panel 32 from the sleeve 52. Obviously, if the detent 53 is torn, it will be a clear indication that the package has been used or tampered with. A perforated tear line 60 is provided to facilitate tearing off and removing the detent 53. A crescent shaped recess 61 is provided in the leading edge of the opposite side of the sleeve 52 to that containing the slot 54 to facilitate gripping the panel 32 for removing it from the sleeve.

For some uses, it might be advisable to fold the opening flap 51 down over the top of the sleeve 52 and secure the detent 53 to the sleeve by applying a piece of adhesive tape, not shown, over the end of the detent. In this case, the envelope would be opened by tearing along the line 60 to allow the sleeve 52 to be separated from the panel 32 A still different embodiment of the package of this invention is shown in FIGS 12-15. A folded fiber-board inner envelope 63 containing a number of compressed cellulose sponges 64 is packaged inside a hermetically sealed sterilizable strippable outer envelope 65 of the type shown in FIGS. 1 and 2 and described hereinbefore. As described in connection with the embodiment of the preceding figures, the inner envelope 63 preferably is formed from a relatively stifl sterilizable sheet material such as virgin paperboard approximately 0.01 inch thick and treated to be water and blood-stain resistant. The inner envelope 63 comprises a positioning panel 66 covering one side of a layer of sponges 64, a top flap 67 foldably connected to one edge of the panel 66 for preventing movement of the sponges longitudinally of the panel, and detachable mechanical means for holding the top flap 67 and the holding flaps 68 in their folded over position with respect to one another and with respect to the panel 66. As shown in FIG. 15, the holding flaps 68 are adapted to be folded down over the sponges 64 and the top flap 67 is adapted to be folded over the holding flaps to secure them in position. The above-referredto detachable mechanical means comprises a relatively short latching flap 69 foldably connected to the edge of the positioning panel 66 opposite to the edge connected to the top flap, a detent 71 presented by the latching flap, and a corresponding cooperating slot 72 in the top flap 67 for receiving the detent 71 when the latching flap is folded down over the top flap, as shown in FIGS. 13 and 14. The cooperating slot 72 has one straight edge 73 adjacent the top edge of the top panel and a semicircular curved edge 74 connected thereto. The detent 71, which is defined by a C-shaped cut in the latching flap 69, is adapted to be inserted easily in the cooperating slot 72 merely by pressing the detent 71 downwardly with one finger to advance it beyond the straight edge 73 of the slot. Similarly, the detent 71 may be removed from the slot simply by bending the portion of the latching flap between the detent and the edge of the flap so as to swing the detent out of the cooperating slot. The latching means may be operated in this manner any number of times for opening and closing the inner envelope 63 to provide access to its contents and for resterih'zing the envelo e and the product remaining therein.

Having now described the invention in specific detail and exemplified the manner in which it may be carried into practice, it will be readily apparent to those skilled in the art that innumerable variations, applications, modifications, and extensions of the basic principles involved may be made without departing from its spirit or scope.

The invention claimed is:

1. A sterile surgical package comprising an outer envelope, a stiff fiber-board inner envelope and a sterile surgical product inside said inner envelope, said outer envelope being hermetically sealed and comprising at least one transparent panel, and said inner envelope comprising (i) at least one panel covering said product,

(ii) a flap foldably connected to one edge of said panel and adapted to be folded over said product to sandwich the product between the panel and the p,

(iii) means for holding said product and preventing movement thereof beyond said panel in a direction parallel to said edge, and

(iv) detachable mechanical means for holding said flap and said panel in their folded over position with respect to one another,

the outside surface of at least one of the panels of said inner envelope bearing printing describing said product and said printing being readable through the transparent panel of said outer envelope, and said inner envelope being capable of being sterilized at temperatures of at least about 250 F. in the presence of live steam without deterioration or detracting from the effectiveness of said inner envelope.

2. A sterile surgical package according to claim 1, wherein said holding means comprise a pair of opposed holding flaps foldable inwardly from opposite edges of one of the panels of said inner envelope and said holding flaps also are adapted to be retained in their folded position by said detachable mechanical means.

3. A sterile surgical package according to claim 1, wherein said detachable mechanical means comprises a latching flap foldably connected to one of said firstmentioned panel and flap and presenting therewith a corresponding slot and detent for holding said first-mentioned panel and flap in their folded over position.

4. A sterile surgical package according to claim 1, wherein said detachable mechanical means is in the form of a fibepbqard'sle'eve which fits over saidfirst-mentioned panel and'flap to hold them i'n thei-r folded over position) l T 5". Ah'sterile surgical paeka geT'according to claim 4, which fnrth'er' {comprises a cooperating :fiap foldabl'y connected to ane'dge of said first-mentionedp'anelop- ,posite to the edge connected to said first-mentionedfiap,

smash? I V nncov'er said opening flap 8E. and said. flap may be folded upwardly to expose one end of the product po- 1 said sleeve is placed :o-ver said panel to hold the sleeve and 'said'holding meanscomprises opposed-holdingfiaps I foldable inwardly'inadir ectio'n normal to the folding of said cooperating flap, said first-mentioned flap, said 7cooperating flap and at leastfone ofsaid holding flaps overlapping one another when they are in their folded over position, and all of said-flaps being heldin their folded over position by said sleeve.

6. A sterile package according tojclaim-5 wherein one of. said holding flaps does not overlap anyi of said other flaps and therefore is adapted. {to-be folded indei i i end of the surgical product when the sleeve is partiallv withdrw to-nncover the'said. nonov'erlapping holdingjfiap i pendently ofjthe other flaps to expose one 7; Asurgiczil package which compnsesa stiff-heatsteriliz'a leienvelo'pe and' a 'snrgicalproduct inside said sitioned onsaid panel for ready' access thereto. '8'. A :surgical package according to claim 7, wherein top and b ottom portio'ns of saidopening flapare adapted toengage'the-topand bottom edges of said'sleeve when iniposition with:respect thereto. 7

9.?A surgical package according ,;to claim 7, wherein thefdispensing sect-ion of said panel is adapted ,to be folded 'under the remainder of-w'the panel to facilitate dispensing of the surgical :product when the opening flap is folded upwardly? ff i 1 v 10. A surgical packageaccording to claim 7, wherein means is provided for securing said opening flap: to said sleeve:.,when the sleeve is in position over said panel and ..-said"pa ckage is adaptedto be opened by tearing a porstion of said opening 'flap.

"11. A surgicalJackag'e according to claim 10, wherein said opening fia'p presents a detentlat ibs inner 'end and a slot is defined ,in one side of said sleeve 'for cooperating envelope; saldenvelope cornp'rising a panel on which the product is adapted tojbepositionedi said panelhaving a dispensing section at one end; top and bdt tom flapsf'fold ablv'connected to the top and bott'orn edges' of 'saidpanel and terminating "shortofl tlie dispensing section thereof; 2

a first side fiap'foldably connected to the side'edge -of said panel oppositeits dispensing end,'said;i top and hottom flaps and said first side flapbeing adapted to overlap oneanother at least partially whenithey are foldeddown over said 'panelyan opening flap -fo ldabl-y "connected to.- the side edge of said panel at the dispensing endthereof;

and a sleeve adapted to slide over said panelqandsaid n flaps when the flaps are foldecl down over saidcpan'el and hold said flapsrin their folded down position' whereby said sleeve may be n ovedwithrespectto ;said panel to the detent is inserted inisaid slot; 7 i

with said-detentfor' l'ocking-thesleeveon said panel when 5 =12 A surgical package accordingto clairn 11, wherein }the defent has an inclined leading'edge' and a trailing further-comprises a hermetically sealed outer envelope enclosing said heat-sterilizable envelope, and, wherein the 'interior and "contents of said -louterrenvelope are sterile.

No references cited. 

7. A SURGICAL PACKAGE WHICH COMPRISES A STIFF HEATSTERILIZABLE ENVELOPE AND A SURGICAL PRODUCT INSIDE SAID ENVELOPE; SAID ENVELOPE COMPRISING A PANEL ON WHICH THE PRODUCT IS ADAPTED TO BE POSITIONED, SAID PANEL HAVING A DISPENSING SECTION AT ONE END; TOP AND BOTTOM FLAPS FOLDABLY CONNECTED TO THE TOP AND BOTTOM EDGES OF SAID PANEL AND TERMINATING SHORT OF THE DISPENSING SECTION THEREOF; A FIRST SIDE FLAP FOLDABLY CONNECTED TO THE SIDE EDGE OF SAID PANEL OPPOSITE ITS DISPENSING END, SAID TOP AND BOTTOM FLAPS AND SAID FIRST SIDE FLAP BEING ADAPTED TO OVERLAP ONE ANOTHER AT LEAST PARTIALLY WHEN THEY ARE FOLDED DOWN OVER SAID PANEL; AN OPENING FLAP FOLDABLY CONNECTED TO THE SIDE EDGE OF SAID PANEL AT THE DISPENSING END THEREOF; AND A SLEEVE ADAPTED TO SLIDE OVER SAID PANEL AND SAID FLAPS WHEN THE FLAPS ARE FOLDED DOWN OVER SAID PANEL AND HOLD SAID FLAPS IN THEIR FOLDED DOWN POSITION, WHEREBY SAID SLEEVE MAY BE MOVED WITH RESPECT TO SAID PANEL TO UNCOVER SAID OPENING FLAP AND SAID OPENING FLAP MAY BE FOLDED UPWARDLY TO EXPOSE ONE END OF THE PRODUCT POSITIONED ON SAID PANEL FOR READY ACCESS THERETO. 